ES2949406T3 - Automated analyzer that punctures aspiration caps - Google Patents

Abstract

An automated analyzer that receives samples prepared for analysis into an automated preanalytical module that is separate from, adjacent to, or integrated with the automated analyzer and a method of operating said automated analyzer. The automated analyzer includes a shuttle transfer station that receives a shuttle conveyor from the automated preanalytical system. The shuttles transport containers with samples that were pre-processed by the pre-analytical system arranged in them. The shuttle transfer station has a shuttle attachment assembly. The clamping assembly has jaws that advance the coupling members until they contact the bottom of the sample containers arranged on the shuttle. The clamp mount, when closed, secures the sample containers on the carrier when the sample is aspirated from the sample containers using a robotic pipettor. The automated analyzer also has a multi-channel puncture tool that is adapted to be carried by a robotic grasping mechanism. The multi-channel puncture tool has multiple puncture members and each of them defines a channel. When the drilling tool pierces the cap of a multi-channel consumable, each channel is in communication with a different channel in the consumable. A pipette may pass through the channel in the lancing tool to aspirate contents or dispense contents into the respective channel with which the channel is in communication. The multi-channel puncture tool has multiple puncture members and each of them defines a channel. When the drilling tool pierces the cap of a multi-channel consumable, each channel is in communication with a different channel in the consumable. A pipette may pass through the channel in the lancing tool to aspirate contents or dispense contents into the respective channel with which the channel is in communication. The multi-channel puncture tool has multiple puncture members and each of them defines a channel. When the drilling tool pierces the cap of a multi-channel consumable, each channel is in communication with a different channel in the consumable. A pipette may pass through the channel in the lancing tool to aspirate contents or dispense contents into the respective channel with which the channel is in communication. (Automatic translation with Google Translate, without legal value)

Description

DESCRIPTION

Automated analyzer that punctures aspiration caps

BACKGROUND OF THE INVENTION

Diagnostic testing of biological specimens is critical to the healthcare industry's efforts to quickly and effectively diagnose and treat diseases. Clinical laboratories performing such diagnostic tests already receive hundreds or thousands of samples daily with increasing demand. The challenge of managing such large quantities of samples has been assisted by the automation of sample analysis. Automated sample analysis is typically performed using automated analyzers which are typically self-contained systems that perform multi-step processes on biological samples to obtain diagnostic results.

Several current automated clinical analyzers offer the user a series of automated tests or assays that can be performed on a provided sample. Additionally, when samples arrive at the laboratory, they are often not ready for analysis. To prepare a sample for analysis with an automated analyzer, a laboratory technician typically transfers an aliquot of the sample from a primary container, as received by the laboratory, to a secondary container that is suitable for the analyzer. Additionally, the technician generally must know what tests are to be performed on the sample so that the technician can select a specific test reagent or diluent to combine with the sample. This can be time-consuming and can lead to operator error and exposure to communicable diseases.

There are also pre-analytical systems intended to help prepare a sample for analysis and further remove the operator from the process between receipt of a sample in the laboratory and test results from the analyzer. However, many of these systems still require significant technician involvement, such as: before loading samples into the pre-analytical system; after the samples have been prepared by the pre-analytical system; and after the analyzers have completed the analysis.

For example, some preanalytical systems can automatically transfer a sample aliquot from a first container to a second container. However, such systems often require a technician to manually match the first and second container identification codes before loading them into the system, which can be time-consuming and error-prone.

Furthermore, many of these systems cannot be integrated with one or more analyzers and, conversely, analyzers cannot be integrated with such systems. In this regard, a technician must be present to manually transfer samples from the preanalytical system to an analyzer and from the analyzer to a storage location once the analysis is completed. This requires skilled labor to perform minor tasks and can create distractions, in that the technician must always be aware of the progress of samples within the preanalytical system and analyzer so that the technician is prepared to transfer samples when they are ready. ready to minimize downtime.

Additionally, current preanalytical systems typically prepare samples at different rates than analyzers evaluate those samples. This further complicates the integration between preanalytical systems and analyzers. In this regard, a technician may be required to continuously monitor samples prepared by the preanalytical system until a complete batch of samples is accumulated for manual transfer to an analyzer. Alternatively, technicians can transfer partial batches to an analyzer, which can reduce analyzer productivity.

Therefore, while current preanalytical systems and automated analyzers are beneficial to the clinical laboratory, the integration and automation of various systems can be improved.

Document EP 2 333 559 A1 from Roche Diagnostics AG, filed on December 9, 2010, describes an automated analyzer with separate modules. The automated analyzer transports processing racks and vessels within the system. The automated analyzer has a plurality of stations such as a distribution station, a separation station and a reaction station.

US 5,262,049 A discloses a fluid collection and distribution system for automatically aliquoting liquids, such as blood serum.

Document EP 3078 972 A1 by F. Hoffman-La Roche, filed on April 7, 2015, describes reagent management for use in conjunction with an in vitro diagnostic test, but stops short of discussing the integration of such systems. with an analyzer. Similarly, WO 2009/024560 A1 of Qiagen GMBH, filed on August 18, 2008, describes a reagent container and a mechanism for recovering liquid from the container but does not discuss the integration of such mechanisms in an analyzer.

BRIEF SUMMARY OF THE INVENTION

The object of the invention is defined by the attached claims.

The present disclosure describes devices, systems and methods for sample processing and analysis. In particular, a parser that is included in a high-performance system is described. In one embodiment, the high-performance system includes a pre-analytical system integrated with the analyzer. In another embodiment, the high-performance system includes at least one additional analyzer and a pre-analytical system integrated with both analyzers. These components (i.e., analyzers and preanalytical system) are modular and can be integrated into several different configurations to suit the diagnostic needs of a particular laboratory.

The particular analyzer described here generally has multiple dishes or levels in a vertical arrangement. A tray can accommodate electronic components and consumable waste including liquid waste and solid waste. Another plate is a processing plate in which sample processing and analysis take place. This plate also stores or inventories large quantities of consumables, including pipette tips, reagent cuvettes, amplification plates, extraction cup holders, a roll of plate sealing material, and the like. In one embodiment, sufficient consumables may be stored in the analyzer to allow the analyzer to operate for a full 8-hour work shift at maximum performance without reloading the system. This plate may also include a plate sealer, orbital shakers, reagent drill-through tools, and readers/detectors to detect an analyte, such as a target DNA.

An additional plate includes a multipurpose robot that includes a Cartesian motion system that allows a payload suspended from said system to traverse the interior of the analyzer above the processing plate. The payload includes a vision system, a consumables clamp, and a multichannel pipettor. The vision system provides barcoding/identification capabilities and to perform other machine vision tasks, particularly as they relate to functions involving the gripper. The consumables gripper moves consumables on the analyzer, such as the reagent cuvette piercing tool and amplification plates. The multi-channel pipettor meets all liquid handling requirements of the analyzer.

BRIEF DESCRIPTION OF THE DRAWINGS

The features, aspects and advantages of the present invention will be better understood with reference to the following description, the accompanying claims and the accompanying drawings, in which:

FIGURE 1 is a front perspective view of a high-performance diagnostic system according to an embodiment of the present disclosure.

FIGURE 2 is a front perspective view of the second system analyzer of FIGURE 1 according to an embodiment of the present disclosure and without its external casing.

FIGURE 3 is another front perspective view of the second analyzer of FIGURE 2.

FIGURE 4A is a perspective view of an extraction container holder according to one embodiment of the disclosure.

FIGURE 4B is an exploded view of the extraction container holder of FIGURE 4A.

FIGURE 5 is a perspective view of a sample container shuttle according to one embodiment of the disclosure.

FIGURE 6 is a perspective view of an amplification board according to one embodiment of the disclosure.

FIGURE 7 is a perspective view of a liquid reagent cuvette assembly according to one embodiment of the disclosure.

FIGURE 8A is a top view of a processing plate according to an embodiment of the present disclosure.

FIGURE 8B is a top perspective view of the processing plate of FIGURE 8A.

FIGURE 9A is a sample container retention assembly according to one embodiment of the disclosure.

FIGURE 9B is a schematic view of the sample container retention assembly of FIGURE 9A engaging a sample container.

FIGURE 9C is a partial perspective view of the sample container retention assembly of FIGURE 9A that includes a drip guard.

FIGURE 10A is a perspective view of a robot assembly according to one embodiment of the disclosure.

FIGURE 10B is a side view of a payload of the robot assembly according to one embodiment of the disclosure.

FIGURE 10C is a partial front perspective view of the payload of FIGURE 10B.

FIGURE 10D is a rear perspective view of a gripper of the payload of FIGURE 10B grasping an amplification plate.

FIGURE 10E is a perspective view of a clamp according to another embodiment of the present disclosure.

FIGURE 10F is a front perspective view of a multichannel pipetter of the payload of FIGURE 10B.

FIGURE 11A is a front perspective view of a battery of holes that houses a drilling tool according to one embodiment of the disclosure.

FIGURE 11B is a front perspective view of the drilling tool of FIGURE 11A. FIGURE 11C is a schematic view of the piercing tool of FIGURE 11A that is used to pierce a seal of a liquid reagent cuvette assembly.

FIGURE 11D is a schematic view of the piercing tool of FIGURE 11A in relation to a pipette tip and the liquid reagent cuvette assembly of FIGURE 7.

FIGURES 11E-11G depict an alternative drilling tool holder and a method for moving the drilling tool of FIGURE 11A to and from the drilling tool holder using the robot assembly of FIGURE 10A.

FIGURE 12 is a rear side perspective view of a consumables drawer according to one embodiment of the disclosure.

FIGURE 13A is a rear perspective view of a plate sealer according to one embodiment of the disclosure.

FIGURE 13B is a rear perspective view of the plate sealer of FIGURE 13A including a lifting and pivoting mechanism.

FIGURE 14 is a front perspective view of an orbital shaker according to one embodiment of the disclosure.

FIGURE 15 is a block diagram of an exemplary architecture of a computer system involving the analyzer of FIGURE 2 that includes example components suitable for implementing methodologies of the present disclosure.

FIGURE 16 is a flow chart of a method of using the analyzer of FIGURE 2 according to an embodiment of the present disclosure.

DETAILED DESCRIPTION

DEFINITIONS

As used herein, the terms “about,” “generally,” and “substantially” are intended to mean that slight deviations from the absolute are included within the scope of the term so modified. Furthermore, when reference is made to specific directions, such as left, right, forward, backward, up and down, in the following discussion, it should be understood that such directions are described with respect to the perspective of a user facing the system described below. during an exemplary operation.

HT SYSTEM IN GENERAL

FIGURE 1 depicts a high-performance system 00 including a first analyzer 2000, a second analyzer 4000, and a pre-analytical system 10, such as the pre-analytical system described in U.S. Provisional Application 62/296,349 ("application '349"). The analyzers 2000, 4000 and the pre-analytical system 10 are modular, so that they can be physically connected and disconnected from each other and also electronically connected and disconnected from each other. Although the second analyzer 4000 is different from the first analyzer 2000 in terms of the operations and tests they perform, it should be understood that the first analyzer 2000 may be a duplicate of the second analyzer 4000 so that the preanalytical system 10 is coupled to at least two of the same analyzers. It should also be understood that the modularity of the preanalytical system 10 allows it to be coupled to any analyzer so configured. As shown, the first and second analyzers 2000, 4000 are arranged on opposite sides of the preanalytical system 10 in a linear arrangement. Although the preanalytical system 10 and the analyzers 2000, 4000 are configured for this physical arrangement, it is contemplated that the preanalytical system 10 can be configured to accommodate more than two analyzers and that the preanalytical system 10 and the analyzers 2000, 4000 can be configured to accommodate more than two analyzers. can be placed in other physical arrangements, such as in an L shape, for example.

ANALYZER IN RELATION TO SYSTEM 10 AND VIPER LT

The second analyzer 4000 can be attached to either side of the preanalytical system 10. In this regard, a sample container shuttle transport assembly 300b of the preanalytical system 10, as shown in FIGURE 7 of the '349 application, can be extended towards the analyzer 4000 when the analyzer 4000 is located to the left of the system 10 (exemplified in FIGURE 1), or a sample container shuttle transport assembly 300a of the pre-analytical system 10 may extend towards the analyzer 4000, where the analyzer 4000 is located to the right of system 10. Said assemblies 300a-b may terminate adjacent to the threshold of the analyzer. However, as described below, the analyzer 4000 has a conveyor that can continue the path of a respective shuttle transport assembly 300 to the analyzer 4000. As used herein, "shuttle" can be a rack or support structure. with a plurality of receptacles, each receptacle sized and configured to receive a sample container.

The 4000 analyzer is similar to and shares many features with the BD Viper™ LT System (Becton Dickinson, Franklin Lakes, NJ), some of which are identified below. The BD Viper™ LT system is not described in detail in this document. However, as explained above, the Analyzer 4000 is a modular system that is configured to operate in cooperation with an automated system for pre-analytical processing of the sample to be analyzed with the BD Viper™ LT System. Said preanalytical system is illustrated as system 10. In this sense, the analyzer 4000 is an adaptation of the BD Viper™ LT System for modular connectivity and high-performance processing and analysis and therefore includes many additional features that are also described below.

STRUCTURAL FRAME

As shown in FIGURES 2 and 3, the analyzer 4000 includes a structural frame composed of various support components 4011, such as metal tube segments, that are configured to support and define various plates or levels for sample processing and analysis. Such dishes may include a supplementary dish 4012, a processing dish 4014, and a multipurpose robot dish 4016. The analyzer 4000 also includes a housing or frame 4010 surrounding its internal components, as shown in FIGURE 1.

CONSUMABLES

Introduction

FIGURES 4-7 represent various consumables that can be used automatically to perform assays on samples, such as liquid-based cytology samples and the like. In particular, the analyzer and its consumables are configured to perform HPV assays that detect multiple HPV stereotypes (e.g., HPV 16, HPV 18, HPV 33, HPV 45, HPV 58, etc.). Such HPV assays may include, for example, the BD Onclarity™ HPV Assay (Becton Dickinson, Franklin Lakes, NJ). The ability to perform such tests is partially supported by the design of consumables. Such consumables include 4062 pipette tips, 03 sample containers, 4030 sample container shuttles, 4020 extraction container holders, 4040 amplification plates, and 4050 liquid reagent cuvette assembly.

Extraction container holder

The extraction container holder 4020 (FIGURES 4A and 4B) is preferably a thermoformed plastic shell that includes a bottom 4025, an upper part 4022 and a plurality of extraction containers 4026. Each extraction container 4026 may contain ferric oxide particles ( "FOX") arranged on a strip to extract DNA from samples and sealed with a lightweight 4023 foil that can be penetrated with a pipette tip before adding a sample.

The bottom portion 4025 of the clamshell is a shallow, rectangular cup with through holes extending therethrough to allow extraction vessels to extend partially through said holes. Thermoformed elements 4028 on the side walls 4027 of the bottom shell 4025 provide a snug fit with the elements in a consumable drawer of the analyzer 4000. Each of the extraction vessels 4026 is loaded into the bottom 4025 so that their sheet sides are in the same direction as the side walls 4027.

The upper part 4022 of the clamshell is in the form of a ribbed insert that falls into a space formed by the side walls 4027 of the lower part 4025 and is locked via a set of protrusions (not shown) on the lower part 4025. A plurality of ribs 4024 extend in a direction transverse to the extraction vessels 4026 to provide structural rigidity to the extraction vessel holder 4020 which provides a clamping force that helps retain the upper shell 4022 during aspiration through a pipette. A plurality of through holes 4021 extend through the top 4022 between adjacent ribs 4024 to allow a pipette tip to access the foil seals 4023 of the tubes 4026. A barcode is located on the top 4022 that helps track information such as the lot, expiration date, and serial number of the contents of the tubes 4026. The extraction container holder 4025 is assembled with enough extraction containers 4026 to perform a single run which, in the depicted embodiment, are 32 extraction vessels in a 4x8 arrangement.

Sample container shuttle

The sample container shuttle 4030 (FIGURE 5) is similar to the shuttle 284 of the '349 application and includes receptacles 4032, each configured to receive a sample container 03. The particular shuttle 4030 depicted includes two rows of six receptacles 4032 for a total of twelve receptacles. However, any number of receptacles 4032 may be provided. For example, shuttle 4030 may include two rows of twelve receptacles 4032 for a total number of 24 receptacles. In the particular analyzer 4000 depicted, a batch of samples can include 12 to 32. Therefore, 1 to 3 shuttles can provide a complete batch to the analyzer 4000.

Shuttle 4030 also includes transverse openings 4036 that intersect corresponding receptacles 4032 to allow a sample container retaining assembly (described below) to access containers 03 disposed therein. The sample containers 03 are the same as the third type container 03 of the '349 application. In this sense, the sample containers 03 include lids with a penetrable seal 09.

amplification board

The amplification plate assembly 4040 (FIGURE 6) includes a plate body 4051. The latching openings 4044 extend to the respective sides 4042 of the body 4041, allowing a gripper of a robot Multipurpose 4300 (FIGURE 10A) engage the 4040 amplification plate assembly from opposite sides thereof. For example, openings 4044a extend across side 4042a and a side (not shown) directly opposite those of side 4042a. Furthermore, openings 4044b extend through side 4042b and through a side (not shown) directly opposite those of side 4044b. This allows the robot 4300 to grasp and lift the plate 4040 while the plate is in different orientations. A plurality of tubes defining amplification compartments 4045 are connected to the plate body 4041 within openings thereof. Such tubes can be provided in the form of 1 x 8 strips of polypropylene tubes inserted into the plate body 4051. The compartments 4054 are provided with dry reagents that are used for the amplification of a target DNA. In this regard, amplification plate 4040 may be color coded for visual identification of reagents contained in compartments 4045 of plate 4040. However, in some embodiments, color coding may be absent.

Liquid reagent plate

The liquid reagent cuvette assembly 4050 includes approximately four separate, linearly arranged cuvettes 4052 that hold bulk reagents. For example, four cuvettes 4052a-d may be provided such that a first cuvette 4052a contains a wash buffer, a second cuvette 4052b contains an acid buffer, a third cuvette 4052c contains a neutralization buffer, and a fourth cuvette 4052d contains a buffer. elution. The volume of said cuvettes 4052 is such that each of them can contain enough reagent to perform at least 20 test passes. This allows sufficient volumes of reagent to be loaded into the 4000 analyzer to last a full 24 hour period without having to be replenished. The first bucket 4052a includes tracks 4056 integrated into its side wall that allow baffle walls (not shown) to be inserted between said tracks 4056 and into the bucket 4052a to help reduce splashing during the filling process. The second bucket 4052b generally has the smallest volume and defines a trapezoidal shaped cavity. This shape provides the required volume while providing a relatively large opening area on one side of the cavity to allow piercing with a sufficiently large tool, such as the 4240 tool, through which a pipette tip accesses the bucket 4052b.

The assembly includes a high strength, penetrable coating material 4058 (see FIGURE 11C) that can be penetrated by the piercing tool 4240 (see FIGURE 11B) to allow a pipette tip 4062 to access the reagents, as described below. continuation. The liquid reagent cuvette assembly 4050 also includes a collar 4054 which, extending around a perimeter thereof, rests on a plate surface and which can be engaged by levers on the plate surface to secure the assembly 4050.

pipette tips

The 4062 pipette tips are provided in 4060 tip holders (see FIGURE 8B). In one embodiment of the analyzer, four 1000 μL tips are used to process each sample. Additionally, a single reagent pipette tip is used with each batch of samples. This helps reduce the number of tips used, as the reagent pipette tip does not come into direct contact with the samples.

Returning to FIGURES 2 and 3, the supplementary plate 4012 is disposed adjacent to the bottom of the analyzer 4000 and is located below the processing plate 4014. The supplementary plate 4012 houses electronic components and waste containers. For example, the supplementary plate 4012 may include a liquid waste reservoir 4002 that receives and houses all liquid waste, such as that from extraction tubes 4026 during a DNA extraction process and from the liquid reagent cuvette assembly 4050 during an emptying process. This tank 4002 includes a pickup device to monitor the empty capacity. The supplementary plate 4012 also includes one or more solid waste tanks 4004 that are located below two solid waste chutes 4210 (see FIGURES 8A and 8B) that extend through the processing plate 4014. For example, a single waste can be located under the 4210 waste landfills and will be able to collect all solid waste. In another example, two solid waste bins may be used to collect used pipette tips 4062 and amplification plates 4040, respectively. Each of said aforementioned solid waste tanks may contain a sensing device similar to that of the liquid waste tank 4002 to detect the level of solid waste. Such a capturing device may include an optical or ultrasonic sensor, for example.

PROCESSING PLATE

Provision

FIGURES 8A and 8B depict the processing plate 4014. The processing plate includes consumables drawers 4100, a plate sealer 4220, orbital shakers 4230, drilling tools 4240, reagent cuvette assemblies 4050, a shuttle transfer station 4250, 4210 waste dumps and readers/detectors.

Drawers

In the depicted embodiment, the processing plate 4014 includes six consumables drawer assemblies 4120, each of which houses the majority of the consumables used in a test workflow, as shown in FIGURES 8A, 8B and 12 In this sense, each of the six drawers 4100 includes, from front to back behind, a pipette tip station 4124, an extraction container station 4126, and an amplification plate station 4128. Stations 4124, 4126, and 4128 are configured to hold pipette tip holders 4060, extraction container holder 4020, and amplification plates. 4040, respectively. Additionally, each consumable drawer 4120 houses an extractor module 4125 within its housing 4122, which is similar to the extractor module of the BD Viper™ LT System, and includes moving magnets that provide the moving magnetic field used to extract DNA. of the samples. Said magnets are housed in each consumable drawer 4120 below the extractor container station 4126 and can be selectively moved in an up and down direction along rails 4127 that are arranged on the side walls separating the compartments. below each of the stations 4124, 4126 and 4128. As shown in FIGURE 12, the extractor 4125 is in an up / extraction position. The consumables drawer assemblies 4120 are located at the front of the analyzer 4000 between two detectors/readers 4260a-b and each include a visual indicator, such as a colored LED, at a front end thereof that indicates its status to a user. so that a user knows that the drawer is currently being used, is ready to use, or needs to be replenished with consumables.

Drawer assemblies 4120 also include a hinged retainer 4121. In the illustrated embodiment, retainer 4121 is a spring-loaded arm that is hingedly connected to housing 4122 immediately behind the pull container station. 4126. The retaining element 4121 has a retaining position and a consumable replacement position. In the retention position, as shown in FIGURE 12, the retention element 4121 extends over the stations 4124 and 4126. In this position, the retention element 4121 is configured to span the respective perimeters of a pipette tip holder 4060 and an extraction container holder 4020 that are located at their respective stations 4124, 4126 while allowing access to them through openings in the retaining element 4121. In this sense, the retaining element 4121 prevents a container holder from extraction 4020 and a pipette tip holder 4060 from inadvertently moving during operation. When consumables in drawer 4120 need to be replaced, drawer 4120 is extended and a locking member (not shown) is released which locks retaining member 4121 in the retaining position. Under the load of a torsion spring (not shown) located within the hinge 4123, the retaining member 4121 rotates about the hinge 4123 to the consumables replacement position which provides space for a user to replenish the consumables within the drawer. 4120.

The processing plate 4014 also includes a single tip drawer assembly 4110 that houses five 96-well tip holders 4060 and is constructed similarly to the drawers 4120, in that it includes visual indicators at a front end thereof. However, the 4110 tip drawer assembly does not include an extractor and is configured to hold multiple 4060 tip holders. These 4060 tip holders provide the fourth pipette tip used for each sample extraction (performed in the consumables drawers), along with tips of reagent and any excess tips that may be necessary due to pickup failures or obstructions. This drawer 4110 is located to the left of the consumables drawers 4120. These drawers 4110, 4120 can be accessed by a user from the front of the analyzer 4000 and can be automated in that the analyzer 4000 automatically locks or unlocks them according to their current state and the state of the analyzer as a whole.

Reagent cuvette station

The reagent cuvette assemblies 4050 are located in a reagent cuvette station that is located between the consumables drawers 4120 and the orbital shakers 4230. These reagent cuvette assemblies 4050 remain in a fixed position. Although the 4050 reagent cuvette assemblies remain in a fixed position and are generally not accessible during operation like the 4100 consumable drawers, it should be understood that the 4050 reagent cuvette assemblies include enough reagent that access to this area is not necessary. during operation.

waste landfill

Separate waste chutes 4210 for amplification plates 4050, pipette tips 4062 and liquid waste extend through the processing plate 4014 and communicate with the respective waste bins 4002, 4004. These allow used consumables to be routed to the bins. of waste 4002, 4004 located under the processing plate. The 4210 waste chutes are located behind the 4110 tip drawer toward the rear of the 4000 analyzer.

Sealant

FIGURES 13A and 13B depict a fully automated plate sealer 4220 that is located in the rear left corner of the analyzer 4000. The plate sealer 4220 has a moving platform 4224 that receives an inoculated amplification plate 4040 and moves toward the plate sealer. plates 4220, best shown in FIGURE 13A. The 4220 Plate Sealer attaches a clear optical seal to the top of the 4040 Amplification Plates. The 4000 Analyzer uses a 4220 Automated Plate Sealer to seal a 4040 Amplification Plate after elution and before mixing plates and target amplification. To provide multiple sealing capability with a single charge, the 4220 sealer uses a roll-based seal that can be provided with a single 4222 roll of sealing material, such as an 800 meter roll, which can be loaded at a time. This volume of sealing material is sufficient to seal 4040 plates for a full year for most applications. However, the 4220 plate sealer may include an optical sensor (not shown). which is configured to detect when the amount of sealing material drops below a certain threshold level indicating that the sealing material needs to be replaced.

Although the 4220 plate sealer is located at the rear of the 4000 analyzer, it is desirable to be able to access the 4220 sealer from the front of the 4000 analyzer to replenish the sealing material. The ability to access components on the back of the 4000 Analyzer through the front of the 4000 Analyzer allows the 4000 Analyzer to be placed directly against a wall in a laboratory, helping to conserve floor space. To facilitate front access, the plate sealer 4220 can be mounted on a lifting and pivoting mechanism 4226, as best shown in FIGURE 13B. The lifting and pivoting mechanism 4226 includes a mobile base 4227 (see FIGURE 13A) mounted on a drive shaft (not shown). The drive shaft is surrounded by a rotating sleeve 4229 which is also connected to the moving base 4227 and can rotate with it. When the optical sensor detects that the seal material is running low, the user is notified. The user can then manually or automatically operate crank 4228 to raise mobile base 4227 across the drive shaft until it clears the surrounding plate. In this raised position, the moving base 4227 is manually or automatically rotated counterclockwise to present the rear of the sealer 4220 to the front of the analyzer 4000. This rotation is limited by the presence of a rotating stop arm. 4223 which is connected to the rotating sleeve 4229 that surrounds the drive shaft. In this regard, the rotating stop arm rotates in unison with the sleeve 4229 and the base 4227 until the stop arm abuts the stationary structure, thus preventing further rotation. This helps prevent excessive rotation that can result in accidental contact of the 4220 Plate Sealer with other equipment. In this position, the empty or nearly empty roll 4222 of sealing material can be easily reached from the front of the analyzer 4000 for replacement. Once a new roll 4222 is incorporated, the sealer 4220 can be rotated clockwise and crank 4228 operated to lower the sealer 4220 back to its operating position.

Drilling tools

The piercing tool 4240 (see FIGURES 11A-11D) includes a plurality of cannulated piercing members 4244 that extend from a tool body 4241 and have a piercing end 4246 shaped to pierce the high-strength seal of the bucket assemblies. of reagent 4050. Said cannulated piercing members 4244 may or may not be co-located in a vertical plane parallel to a longitudinal axis of the tool body 4241. The cannulated piercing members 4244 define openings 4242 large enough to receive a pipette tip 4062 in their inside. The tool 4240 also includes a pair of link members 4248 extending upwardly from the body 4241 that have engaging openings 4249 that receive holding members 4346 of a gripper 4340 of the robot 4300, as shown in FIGURE 11C. The piercing tool 4240 punctures a seal of a reagent cuvette assembly and is left in place to provide channels through which the pipette tip 4062 can aspirate liquid reagents, as best shown in FIGURE 11D.

Hole Batteries/Drilling Tool Holders

Two piercing/poking tools, each associated with a reagent cuvette assembly 4050, sit within respective batteries of wells or holders 4270 toward the center rear of processing plate 4014 until they are used to puncture a set of reagent cuvette 4050. The holder 4270 includes a platform 4272 that is within a cavity 4274 that houses the tool 4240. The platform 4272 has raised side edges that are coupled to the periphery of the tool 4240 so that when the tool 4240 is placed in the holder 4270, the tool 4240 rests on the platform 4272 in a precise location while waiting to be picked up by the robot 2300, as best shown in FIGURE 11A.

FIGURES 11E-11G illustrate a battery of holes/alternative drilling tool holder 4280. The holder 4280 includes a base 4282, one or more side walls 4288, alignment posts 4287a-b and retaining members 4284. The posts 4287a-b They extend from the base 4282 and have conical end portions 4289 that are configured to interface with openings (not shown) in the bottom of the drilling tool body 4241. The conical end portions 4289, best shown in the FIGURE 11G, help align the tool 4240 within the holder 4280 when placed thereon. The one or more side walls 4288 extend from the base 4282 generally on a front and rear side of the holder 4280 defining a housing space for the tool 4240. As shown, the side walls 4288 do not extend from the base 4282 in the left and right sides thereof, which provides space for the retaining members 4284 to pivot. However, side walls extending from a left and right side of the base 4282 are contemplated to further define the housing for the drilling tool 4240 provided that such side walls provide sufficient free space for the movement of the retaining members 4284, as described below.

The retaining members 4284 extend from the base 4282 and are located at opposite ends of the support 4280 at a distance sufficient to allow the drilling tool 4240 to be disposed between them. The retaining members 4284 each include one or more beveled surfaces 4285, such as the first and second beveled surfaces 4285a-b. The beveled surfaces 4285a-b face inwardly toward a center of the support 4280. Additionally, the second beveled surface 4285b is generally positioned further inward than the first beveled surface 4285a. Each retaining member 4284 also has a protruding surface 4286 facing the base 4282. The retaining members 4284 are movable between the first and second positions, as by means of a pin connection to the base 4280, but are biased in the first position, as by a spring (not shown). . In this regard, when the retaining members 4284 are in the first position, a drilling tool 4240 supported by the support 4280 is restricted from vertical movement by the projecting surfaces 4286 of the retaining members 4284, as shown in FIGURE 11E . While in the second position, as shown in FIGURE 11F, the protruding surfaces 4286 disengage from the drilling tool 4240. Thus, the drilling tool 4240 is no longer restricted by the retaining members 4284 and can be lifted from the support 4280 while the retaining members 4284 are in the second position.

Sample Container Retention Assembly

The sample container retention assembly 4250 (FIGURES 9A and 9B) is similar to the sample container retention assembly 1100 of the '349 application, in that it includes a clamp assembly 4252 that closes towards a shuttle 4030 arranged within the holding assembly to retain the shuttle 4030 and the containers 03 within the shuttle 4030 while aliquots are aspirated from the containers 03. In this sense, the holding assembly 4252 includes latching members 4253 that are configured to protrude through of second transverse openings 4036 in the shuttle 4030 when the clamping assembly 4250 is closed to engage a skirt 07 at a lower end of the sample containers 03, as best seen in FIGURE 11C. These hooking members 4253 penetrate/bite into the skirts 07 of the respective containers 03 to prevent the containers 03 from being inadvertently removed from the shuttle 4030 during suction. Additionally, each holding assembly 4252 includes a drip screen 4251 connected thereto. Each drip screen 4251 includes a plurality of semicircular notches that are configured to partially receive a sample container 03. In this sense, when the clamping assemblies 4252 engage sample containers 03, as shown in FIGURE 9A, the drip screens 4251 of the respective clamping assemblies 4252 interface to substantially fill the spaces between the sample containers 03, which helps prevent sample dripping from falling between the containers 03 and onto the shuttle 4030 or conveyor 4254. To provide For additional protection against dripping, a drip guard 4259 may cover the clamping assembly 4250 except directly above the sample containers 03 and conveyor 4254, as best shown in FIGURE 9C. The 4251 Drip Screens and 4259 Drip Guard provide easy-to-clean surfaces in the event of a sample drip.

Additionally, the sample container holding assembly 4250 includes a conveyor belt 4254 that receives a shuttle from the preanalytical system 10 and moves it into position between the holding assembly 4252. In this regard, the conveyor belt 4254 receives a shuttle 4030 from an exit rail of the shuttle transport assembly 300 of the preanalytical system 10. When it is time to return the shuttle 4030 to the preanalytical system 10, a motor 4256 starts a drive mechanism (not shown) that slides the retaining assembly 4250 along a track 4257 on a suspended platform 4255 so that the conveyor 4254 aligns with an exit lane of the shuttle transport assembly 300. The conveyor 4254 operates in two directions to receive and return the shuttle 4030.

Orbital shaker

The orbital shakers 4230 (see FIGURE 14) oscillate the sealed amplification plates 4040 in a circular motion to completely rehydrate a dry reagent mixed with an eluted sample within the compartments 4045 of the sealed amplification plate 4040. Two of these are They are placed in the rear center of the analyzer 4000 behind the extraction reagent cuvettes 4050. Of course, they could be provided more or less, as necessary. The orbital shaker 4040 includes a platform 4042 on which the amplification plate 4040 rests and includes at least two automated arms 4046 that are configured to maintain the plate 4040 on the platform 4042 during operation. In this regard, the arms 4046 may be positioned at the corners of the platform 4042 and may move inward in a radial direction to hold the amplification plate 4040 in position and outward in a radial direction to release the amplification plate 4040 for pickup. the 4300 robot.

Detector/reader

Two 4260a-b detector/readers are located at opposite ends of the 4000 analyzer and have cavities facing the center of the 4000 analyzer. These 4260a-b readers are similar to the readers used in the Viper™ LT System. In this sense, the 4260a-b readers have a housing that receives sealed amplification plates 4040. The 4260a-b readers also have a thermal cycler that is used to amplify a target analyte within the 4040 amplification plates and a detector that detects the target analyte using a set of LED illuminators, for example.

Robot

As depicted in FIGURES 10A-10F, the multipurpose robot 4300 is suspended on the robot plate 4016. The multipurpose robot 4300 is an automated system for mass transfer and optical interrogation (e.g., barcode reading). which is suspended above the processing plate 1014 and includes a Cartesian robot 4301 that carries a payload.

The Cartesian robot 4301 includes two linear rails 4302a-b mounted orthogonally. Each of the two linear rails 4302a-b has at least two optical limit switches (not shown) to ensure that the payload 4306 is not driven to full extension and to facilitate initialization. Due to the size of the payload 4306 and the fact that it is suspended near the processing plate 4014, there is a possibility of collisions that are desirably avoided. To help prevent collisions, a third optical sensor is provided on the first linear rail 4302a. This allows the 4300 robot to instantly detect which half of the analyzer (left/right) it is on, ensuring that the center of the 4000 analyzer can be found and a safe boot and initialization procedure can be used.

Payload and rotation stage

The 4306 robot payload sits beneath the 4301 Cartesian robot and provides vision, pipetting, and plate transfer functionality. In this sense, the payload 4306 includes a rotating stage 4310, a vision system 4320, a gripper module 4340, a multichannel pipettor 4350 and a back panel connector 4360. The robot payload 4306 is connected to the Cartesian robot 4301 through the rotating stage 4310. The rotating stage 4310 can rotate the payload 4306 approximately 180 degrees around a vertical axis providing flexibility of movement to the gripper 4340, the pipettor 4350 and the vision system 4320.

Consumables handling part

vision system

The vision system 4320 and gripper 4340 comprise a consumables handling module 4320. The vision system 4320 may be any conventional vision system that is capable of reading barcodes and performing other machine vision tasks. An exemplary vision system includes the In-Sight 5600 vision system (Cognex Corporation, Natick, Massachusetts). This vision system 4320 is attached to the vertical stage 4322 along with the clamp 4340, which allows the vision system 4320 to move up and down together with the clamp 4340 and allows the vision system 4320 to focus on An objective. Such movement along the vertical stage is carried out by the 4330 motor.

Gripper

The clamp module 4340 sits on an opposite side of the back panel connector 4360 from the multichannel pipettor 4350. The clamp module 4340 includes, as mentioned, is connected to the vertical translation stage 4322 that varies the height of the clamp 4340 and arms 4344a-b that translate horizontally relative to each other to engage a consumable item. Such arms 4344 have gripping fingers 4349 (see FIGURE 11C) which may have latching elements or protuberances 4345 projecting laterally therefrom and which are used to help secure a consumable item having corresponding latching notches (see FIGURE 11C). . The clamp 4340 also includes clamping members 4346 that project downwardly from the horizontal members 4347 of each arm 4344a-b (see FIGURE 11C). Said holding members 4346 each include a laterally projecting member 4348 that is configured to be received by an engagement opening 4249 in the link members 4248 of the drilling tool 4240. As each arm 4344 is capable of moving relative to the others, each clamping member 4346 is capable of moving relative to the other clamping member. This allows the clamping members 4346 to engage the linking members 4248 to firmly secure the drilling tool 4240 during a drilling operation, and also to disengage from the drilling tool 4240 to leave it in place within the holder 4270, 4280 or above the liquid reagent cuvette assembly 4050. Similar to the movement of the gripping arms described elsewhere herein, the gripping members are capable of relative lateral movement such that they are laterally further apart in one position and laterally closer together in another position.

FIGURE 10E depicts an alternative gripper module 4340'. The gripper module 4340' is similar to the gripper module 4340 in that it includes gripping arms 4344a'-b' that include protrusions 4345. However, the gripper module 4340 also includes presence sensors 4341 that are configured to detect the presence of a consumable item between the gripping arms 4344a'-b'. For example, as shown, each arm 4344a' and 4344b' includes a sensor 4341 which is a switch type sensor. Such sensor 4341 is positioned so that it can be deflected by a consumable item, such as the plate 4040, when the gripping arms 4344a'-b' grip said consumable item between them. Therefore, whenever the gripping arms 4344a'-b' grip the consumable item so that a sensor 4341 is deflected, its presence is detected. However, when the gripper arms 4344a'-b' release their grip, the sensor 4341 returns to its normal position indicating that no consumable item is present. Although a deflectable switch type sensor is shown. Other sensors are contemplated, such as optical sensors, for example.

In FIGS 11E-11G and also 11C-11D, a method of puncturing the liquid reagent cuvette assembly 4050 is depicted. As shown in FIGURE 11E, the drilling tool holder 4280 is mounted on the processing plate 4014 and the drilling tool 4240 is retained in the holder 4280 by retaining members 4284 which are in the first position. Said support 4280 may be located in the rear right corner of the system 4000 adjacent to the orbital shakers 4230 shown in FIGURE 8B. The multipurpose robot 4300 moves toward the drilling tool holder 4280 and lowers the gripper module 4340 to a height above the drilling tool 4240 so that the protruding members 4348 of the gripper are aligned with the engagement openings 4249 (see FIGURE 11B for openings) of the drilling tool 4240, best shown in FIGURE 11E.

While in this position, the gripping arms 4344a-b are separated so that the protruding members 4348 are received in the corresponding engagement openings 4249. When this occurs, the gripping fingers 4349 engage the retaining members 4284 on the first surface beveled 4285a, or adjacent to it, to overcome its stress and push the retaining members 4284 outward, towards the second position, as better shown in FIGURE 11F. This provides clearance for the drilling tool 4240 to be lifted from contact with the support 4280. Thus, with the retaining members 4284 held in the second position by the fingers 4349 and with the projections 4348 engaged in the openings 4249, the tool The drilling tool 4240 is removed from the holder 4280 through the collet module 4340 until the drilling tool body 4241 clears the protruding surface 4286 of the retaining members 4284.

Once the drilling tool 4280 clears the retaining members 4284, the multipurpose robot 4300 moves the gripper module 4340 and the drilling tool 4280 toward a liquid reagent cuvette assembly 4050 that can be placed in front of the tool holder 4280. and further toward the center of system 4000, as shown in FIGURE 8B. The robot 4300 then places the drilling tool 4280 on the bucket assembly 4050 so that the cannulated drilling members 4244 are each aligned with a respective bucket 4052a-d, as best shown in FIGURE 11C. Subsequently, the gripper module 4340 lowers the drilling tool 4240 so that the drilling members 4244 puncture the coating material 4058. When the coating material 4058 is completely punctured, the tool body 4241 sits on the walls 4051 that separate each bucket 4052a-d. Said walls 4051 support the weight of the drilling tool 4240. The cannulated drilling members 4244 have a length large enough to completely penetrate through the coating material while being short enough to place the drilling members 4244 completely above the surface of any reagent found in the respective cuvettes 4052a-d. Additionally, the cannulated piercing members 4244 provide uniform openings 4242 that are large enough to allow easy passage of a pipette tip 4062. This helps prevent incidental contact with the coating material 4058 that could push out an amount of free reagent. of the 4062 pipette tip when using the 4062 pipette tip to withdraw reagent from the 4050 cuvette assembly.

Once the coating material 4058 is punctured and the tool 4240 is well supported by the bucket assembly 4050, the gripper module 4340 releases its grip on the tool 4240 by moving the arms 4344a-b toward each other so that the projections 4348 are removed from the openings 4249. Thereafter, the robot 4300 carries the payload 4310, which includes the gripper module 4340, away from the bucket assembly 4050. In this sense, the payload 4310, which also includes the pipettor 4350, may be moved to a location of unused disposable pipette tips 4062 which may be located in the tip drawer 4110 shown in FIGURE 8B. The pipettor 4350 is then lowered to retrieve one or more pipette tips 4062. The robot 4300 can then move the pipettor 4350 over the piercing tool 4240 and cuvette assembly 4050 to align the pipette tip 4062 with an opening 4242. of the tool 4240. The pipette tip 4062 is then lowered into the selected cuvette 4052, as shown in FIGURE 11D, through the corresponding opening 4242 to aspirate reagent from the cuvette 4052. The aspirated reagent can then be carried to another location within the 4000 system as necessary. The reagent is then dispensed into an appropriate container and the 4062 pipette tip is discarded. Retrieval of a 4062 pipette tip, aspiration of a reagent through the piercing tool, and disposal of the 4062 pipette tip They can intervene several times until the reagent runs out. The 4000 system keeps track of the amount of reagent remaining and will alert the user when the reagent needs to be changed. This is described elsewhere in this document.

When the drilling tool 4240 is returned to the holder 4280, such as when the liquid reagent cuvette 4050 needs to be replaced or for some other reason, the robot 4300 moves the gripper module 4340 over the drilling tool 4240 resting on the assembly. reagent cuvette 4050 and engages the piercing tool 4240 by moving the projections 4348 to the openings 4249, as described above. Once the drilling tool 4240 is engaged by the clamp assembly 4340, the robot 4300 carries the drilling tool 4240 away from the reagent cuvette assembly 4050 to a position above the holder 4280. The clamp assembly 4340 is then lowers so that the drilling tool body 4241 comes into contact with one or more beveled surfaces 4285a-b. As the drilling tool 4240 descends toward the holder 4280, the drilling tool body 4241 slides along one or more of the beveled surfaces 4285a-b that push the retaining members 4284 outward from the first position to the second position, as best shown in FIGURE 11G. With the retaining members 4284 positioned to provide clearance for the drilling tool 4240, the drilling tool 4240 is lowered further to engage the posts 4287a-b that align the drilling tool 4240 with respect to the support 4280. Near the bottom of the drilling tool descent 4240, the gripping fingers 4349 may also engage the retaining members 4284 on or adjacent to the beveled surface 4285a to help maintain them in the second position, which is illustrated in FIGURE 11F. Once the tool 4240 is fully seated in the holder 4280, the gripping arms 4344a-b move laterally toward each other, which disengages the protruding members 4348 from the drilling tool 4240 and also disengages the gripping fingers 4349. of the retaining members 4284. In other words, the pair of gripping arms moves laterally from a first position in which the arms are further apart to a second position in which they are closer together. The gripping fingers engage and push back on the retaining members in the farthest position and do not engage the retaining members when they are in their closest position. In this regard, the retaining members 4284 return to the first position shown in FIGURE 11E under their own request, thus retaining the drilling tool 4240 until it is needed again.

Multichannel pipettor

The 4350 multi-channel pipettor is connected to the 4360 rear panel connector on a side opposite that of the consumables handling portion. The multichannel pipettor 4350 includes a plurality of liquid handling assemblies 4352a-e that connect directly to the rear panel connector 4360. In the depicted embodiment, there are five liquid handling assemblies 4352: a first liquid handling assembly 4352a, a second liquid handling assembly 4532b, a third liquid handling assembly 4532c, a fourth liquid handling assembly 4532d and a fifth liquid handling assembly 4532e. Each liquid handling assembly 4532 includes a main board assembly 4370 and a pipette assembly 4380. The liquid handling assemblies 4352a-e are connected to the back panel connector 4360 adjacent to each other in close proximity.

Each 4370a-e main board assembly helps provide data, power, and positive/negative air pressure to a corresponding 4380a-e pipette assembly. In the depicted embodiment, there are five 4370ae pipette assemblies. Each main board assembly 4370a-e is similar to the main board assembly 1401 described and shown in FIGURES 27a and 27B of the '349 application. In this sense, each main board assembly 4370a-e includes a housing 4372 with various components arranged therein, such as a PCB, positive and negative pressure inlets, a valve, and a liquid/gas conduit in communication with the inlets and The valve. The main board assemblies 4370a-e also include a z-drive mechanism that includes a vertical rail 4374 on one side of the housing 4372 and a motor 4376 and a drive shaft (not shown). The drive shaft is arranged inside the housing 4372.

One of the pipette assemblies 4380a-e is reserved for clean reagent transfers and, therefore, a pipette tip 4062 carried by said reserved assembly 4380 is never contaminated with sample. This allows a single 4062 reagent tip to be used for the entire extraction process, minimizing the number of tips required for an assay workflow. As each pipette assembly 4380a-e is capable of independently moving in a z direction, the pipette tip 4062 of said reserved pipettor 4380 can be independently inserted through the channels 4242 of the piercing tool 4240 and into the appropriate liquid content reservoir of the 4050 plate, as best shown in FIGURE 11. There is no contact between the 4062 pipette tip and a solid surface.

Each pipette assembly 4380a-e is similar to the pipette assembly 502 of FIGURES 17A-17D and the pipette assembly 1402 of FIGURES 27A and 27B of the '349 application, with the exception that each pipette assembly 4380a-e It is not hinged to its respective 4370a-e main plate assembly and does not rotate in multiple articulation positions. Each pipette assembly 4380a-e is rotationally constrained and moves in a vertical z direction along the vertical rail 4374 via the motor 4376. Therefore, the first, second, third, fourth and fifth pipette assemblies are capable to move independently in a vertical or z direction. Other than that, the pipette assemblies 4380a-e are constructed similarly to the pipette assemblies 502 and 1402, particularly with respect to their pipette channel assembly (not shown) and pipette tip ejector assembly.

The back panel connector 4360 is similar to the back panel connector 1600 of FIGURES 29A and 29B of the '349 application, with the exception that the back panel connector 4360 is configured to have multiple liquid handling assemblies 4352a-e and consumable handling assemblies 4320 connected thereto. In this sense, the back panel connector 4360 connects to the main board assemblies 4370a-e of each liquid handling assembly 4352a-e and to the corresponding electronic boards that operate the consumable handling part. The 4360 backplane connector includes various input and output connectors (not shown), such as Ethernet, multi-pole, positive pressure input, and negative pressure input connectors, to supply the 4320 consumables handling module and handling assemblies. of liquids 4352a-e the necessary energy, pressure and data signals. This helps reduce or eliminate external wiring that could become snagged and can be difficult to manage with multiple 4352a-e liquid handling assemblies connected in such close proximity. The required inputs may be provided to the rear panel connector 4360 through the rotary stage 4310. In this sense, the rear panel connector 4360 may act as a manifold for air pressure and other inputs/outputs.

FIGURE 15 represents a general architecture of a computer system of the analyzer 4000. The computer system may be a subsystem within the system 1300 of FIGURE 26 of the '349 application which represents a computer system diagram of the high-performance system 00. In In this sense, the cross-instrument bus 4404 and the workflow computing device 4540 are the same as the bus 1320 and the computing device 1330 depicted in FIGURE 26 of the '349 application. Furthermore, the computing device 4410 is similar to the computing device 1360 and is described in more detail herein along with its inputs and outputs within the analyzer 4000.

Computer control device and processor

The computer control device 4400 may be any general-purpose computer and may contain a processor 4412, memory 4414, and other components typically present in general-purpose computer control devices. However, the computing control device 4410 may include specialized hardware components to perform specific computing processes. The processor 4412 may be any conventional processor, such as a commercially available CPU. Alternatively, the processor 4412 may be a dedicated component such as an application specific integrated circuit ("ASIC") or other hardware-based processor.

Memory 4414 may store information that can be accessed by processor 4412, including instructions 4416 that can be executed by processor 4412. Memory 4414 may also include data 4418 that can be retrieved, manipulated, or stored by processor 4412. The memory 4414 may be of any non-transitory type capable of storing information accessible by the processor 4410, such as a hard disk, memory card, ROM, RAM, DVD, CD-ROM, write-capable and read-only memories.

Instructions 4416 may be any set of instructions to be executed directly, as machine code, or indirectly, as scripts, by the processor 4412. In that sense, the terms "instructions", "application", "steps" and "programs " may be used interchangeably in this document. Instructions 4416 may be stored in object code format for direct processing by processor 4412, or in any other computing device language, including scripts or collections of stand-alone source code modules that are interpreted on demand or compiled in advance.

In one embodiment of analyzer 4000, the computing device 4410 may include multiple sets of instructions 4416. For example, each assay to be performed may have associated multiple sets of instructions which may include instructions that operate the multipurpose robot 4300 to optically scan consumables, grasp and move consumables, and aspirate liquid samples.

Data 4418 may be entered and displayed through a graphical user interface ("GUI") that may be displayed on the display interface 4420 that is specifically associated with the analyzer 4000, or the display interface 1332 of FIG. 1 and the FIGURE 26 of application '349 that is associated with the entire high-performance system 00. Data 4418 can also be input from the vision system 4320 of the multipurpose robot 4300 or scanners within the pre-analytical system 10. Data 4418 can also be input obtained through door sensors, temperature sensors and the like, to obtain information about certain conditions and activities occurring within the analyzer, such as the location of particular consumables and air quality, for example.

This data 4418 can be digitally added to particular identification codes (e.g., barcode serial numbers) in a relational or field-deployed database, which can also be stored in memory 4414. This helps the Analyzer 4000 keeps track of various consumables within Analyzer 4000 and helps provide certain information to processor 4412 during the execution of processor 4416 instructions without requiring user input. For example, the amplification plate 4050 may have an identification code that may be associated with a barcode located on an exterior surface thereof that may be added to the database with certain stored data, such as the type of reagents stored. in it and what reagents have already been used. This allows the analyzer to check its inventory to determine when reagents and other consumables are running low or insufficient to perform additional assays. In another example, a shuttle 4030 may have an identification code that may be added to the database with certain stored data, such as data related to each of the sample containers 03 carried by the shuttle 4030, such as the name of the patient, the test to be performed, the processing parameters and the like. In a further example, when the analysis is completed, the assay result can be associated with the particular sample within the database so that a user can easily retrieve the results through access to the workflow computing device 4540, since said results can be communicated to it through device 4410.

Although FIGURE 15 functionally illustrates the processor 4412, memory 4414, and other elements of the computer control device 4410 as being within the same block, the computer control device 4410, processor 4412, and/or memory 4414 may be composed of multiple processors, computer control devices and memories, respectively, which may or may not be stored within the same physical housing. For example, the memory 4414 may be a hard disk or other storage medium located in different housings than the computer control devices 4410. Accordingly, it should be understood that references to the processor 4412, the computer control device 4410 and the memory 4414 include references to a collection of processors, computer control devices, and memories that may or may not operate in parallel.

Display interface

The display interface 4420 may be specifically associated with the analyzer 4000 and may only display information about the analyzer 4000 and may also be integrated into the structure of the analyzer 4000. However, display interface 4420 is optional (indicated by dashed lines in FIGURE 15) and, in the embodiment shown in FIGURE 1, is not included, as the general system display interface 1332 is used instead. However , when display interface 4420 is included, interface 4420 may be a monitor, LCD panel, or the like attached to a front panel of housing 4010 or located remotely from analyzer 4000. The display interface may display a GUI, indicators user information, user instructions and other information that may be relevant to a user.

input interface

The user input/control interface 4430 allows a user to navigate the GUI and again may optionally be provided as a separate component of the overall system input interface provided by the display interface 1332 of FIGURE 1. However, when user input/control interface 4430 is provided, said interface may be a touch panel, keyboard, or mouse, for example. Additionally, input interface 4430 may be integrated into display interface 4420 such that the same device that displays indicators and the like is the same device that allows a user to respond to said indicators.

As depicted in FIGURE 15, the computing control device 4410 may be connected to the workflow computing device 4540 which is used to integrate all components of the high-performance system 00, such as the first analyzer 2000 and the pre-analytical system 10. , and to integrate with a laboratory information system ("LIS") 4550 of a particular laboratory. Thus, information relevant to the analyzer 4000 that originates within the preanalytical system 10 can be communicated to the analyzer 4000 through the workflow computing device 4540. Similarly, information relevant to the preanalytical system 10 that originates from the Analyzer 4000 may communicate via computing control device 4540 to workflow computing device 4540, which communicates that information to preanalytical system 10. Such information may also be supplemented with information obtained from LIS 4550 via workflow computing device 4540. , such as patient information and the like.

The computer control device 4410 is also connected to multiple components within the analyzer 4000 to share information back and forth, such as instructions and data. Some of the components that are connected to the computer control device via the internal bus 4502 include several of the components described above that are located on the processing plate, such as the plate sealer and orbital stirrers. Additionally, the computer control device may be connected to the detector/readers 4260a-b and the multipurpose robot 4300. Such connections to the computer control device 4410 allow the computer control device 4410 to provide instructions to and receive information from said components. For example, the multipurpose robot 4300 may receive instructions from the computer control device 4410 to retrieve and apply the drilling tool 4240 to a reagent cuvette assembly 4050 or to lift and move an amplification plate 4040 from one location to another. Therefore, operations performed by the internal components of the analyzer 4000 are generally the result of instructions provided by the processor 4410, since the analyzer 4000 is fully automated.

In a processing and analysis method 4600 (FIGURE 16) using the analyzer 4000, the analyzer 4000 moves samples through four functional stages: sample transfer, extraction, preamplification, and amplification/detection. These stages are now described.

Sample transfer

Upon notification 4600 from the preanalytical system 10 that a batch of samples (up to three shuttles 4030) has been prepared and is ready for transfer and the analyzer 4000 acknowledges receipt of said notification, the analyzer 4000 advances to the sample transfer step. samples 4604. In the sample transfer step, the preanalytical system 10 advances the shuttles 4030 to the analyzer 4000 through the shuttle transport assembly 300 in a sequence of one to three shuttles 4030. The size of the batches transported to the analyzer 4000 is a matter of design choice. For example, when three shuttles are transferred, the first two shuttles 4030 can contain 12 sample containers 03 and the last shuttle 4030 can contain 8 sample containers. The first shuttle will typically include 2 control sample containers that are among the 12 sample containers transported by it to the analyzer. The two control sample containers will normally be at the front of the shuttle when transported to the analyzer. Therefore, in this example, 30 sample containers are brought to the analyzer in one batch, with two controls. These shuttles 4030 are manipulated one at a time by the analyzer 4000 such that the samples contained in the shuttle 4030 move completely through the sample transfer process and return to the preanalytical system 10 before being moved to the analyzer 4000. next shuttle 4030 in queue.

Reception and fastening of the shuttle

As described in the '349 application, the shuttle transport assembly 300 of system 10 includes an input lane and an output lane in which one of them is dedicated to the transfer of shuttles to the analyzer 4000 and the other to the return of shuttles from the analyzer 4000. Before receiving the shuttle 4030 from the preanalytical system 10, the analyzer 4000 ensures that the conveyor 4254 of the shuttle retention assembly 4250 is aligned with the appropriate rail of the shuttle transport assembly 300. from then on, the shuttle 4030 is advanced out of the preanalytical system 10, through a port between the side walls of the two systems 10, 4000, and over the conveyor 4254 into the analyzer 4000. Thus, the preanalytical system 10 delivers a shuttle 4030 to the analyzer 4000.

Once the shuttle 4030 has completely transitioned to the analyzer 4000, the preanalytical system 10 stops its forward mechanism and waits for a ready acknowledgment from the analyzer 4000 to send a subsequent shuttle 4030. Meanwhile, the analyzer 4000 moves the shuttle 4030 to its mating position toward the center of the analyzer 4000 until it is positioned between the clamping assembly 4252. Once the shuttle 4030 has been matched to the desired location by use of optical sensors, the clamping assembly 4252 completely holds the shuttle 4030 and the hook members 4253 engage the skirts 07 of the sample containers 03, such as by pinching them, to hold them in place for liquid transfer.

Thereafter, a pipette assembly 4380 penetrates a penetrable lid 09 of one of the sample containers 03 into the shuttle 4030. The geometry of the punctured lid creates the possibility for the pipette assembly 4380 to generate on the container 03 a significant amount of lifting force when pipette tip 4062 is removed from container 03 after aspiration. Latching members 4253 help ensure that each container 03 remains seated.

Sample aspiration and transfer

Once the shuttle 4030 with its containers 03 are fully seated and secured, the analyzer 4000 moves to the aspiration and sample transfer portion of sample transfer step 4604. For each set of four containers 03 on the shuttle 4030 , starting with the pair of containers 03 in the innermost position, the pipettor 4350 uses two of its five sets of pipettes 4380 with a pipette tip 4062 loaded therein to puncture the penetrable cap 09 of each pair of containers 03, mix the sample and aspirate the required sample volume from containers 03. Once the correct sample volume has been aspirated, the 4062 pipette tips are removed. A second pair of 4380 pipette assemblies is used to perform the same process on the next pair of sample containers 03 on shuttle 4030 moving in a direction away from the center of shuttle 4030.

Once four samples are aspirated and arranged within the pipette tips 4062, the multipurpose robot 4350 moves to a pre-designated consumables drawer 4120 and distributes the four samples into a row of the 4x8 grid of extraction vessels 4026. that have been pre-punctured before the sample transfer process. After distributing the samples into the extraction vessels 4026, the four used pipette tips 4062 are ejected through the tip waste chute 4210. This process is repeated for the remaining two sets of four samples in the shuttle 4030 (in the case of the third shuttle, the only remaining set of four), until the entire set of containers 03 contained in the particular shuttle 4030 has been transferred to the extraction containers 4026.

Shuttle return

Once the samples from all vessels 03 have been successfully transferred to the extraction vessels 4026, the shuttle 4030 can be returned to the pre-analytical system 10. To prepare for this, the clamping mechanism 4252 in the assembly is released. shuttle retention assembly 4250, removing the hooking members 4253 from the containers 03 on the shuttle 4030. After availability negotiation between the preanalytical system 10 and the analyzer 4000, the shuttle retention assembly 4250 itself moves in a direction towards back and forth along the platform 4255 so that its conveyor 4254 aligns itself with a sample return rail of the shuttle transport assembly 300 in the preanalytical system 10. Once the holding assembly 4250 is in position, conveyor 4254 is used to pass shuttle 4030 out of analyzer 4000 and back to preanalytical system 10.

These steps are repeated until the analyzer 4000 has received the three shuttles 4030, their samples have been transferred to an extraction vessel 4026 and returned to the pre-analytical system 10. At that time, the sample transfer step 4604 is completed. Thus, in this embodiment, 32 tips have been consumed and the analyzer 4000 proceeds to the extraction step 4606.

Extraction

Once all samples have been moved to extraction vessels 4026, analyzer 4000 begins extraction process 4606. During extraction, DNA is eluted from samples and isolated to prepare for PCR amplification. The extraction step 4606 is carried out using pipette assemblies 4380a-e in the multifunctional robot 4300 and the extractors integrated in the particular consumables drawer 4120 in which the extraction is being performed.

Using the pipettor

To minimize the number of 4062 tips required to perform the assay workflow, the 4300 multifunctional robot includes five sets of 4380a-e pipettes. This allows the 4000 analyzer to hijack a single 4380 pipette assembly for clean reagent distributions that do not come into contact with the sample and therefore do not contaminate the tip with the sample. This fifth 4380 pipettor finds its use in the extraction protocol, reducing the frequency with which contaminated 4062 tips must be discarded.

At some point before beginning the extraction (either during a previous run if there was enough bulk liquid reagent left in cuvette 4052 or when preparing for the run in question), a reagent cuvette assembly 4050 is punctured with a tapping tool. perforation 4240, which is left at the same point to provide channel 4242 through which reagent tip 4062 can aspirate liquid reagents. Application of the drilling tool is performed by gripper 4340 of the multifunctional robot 4300, as described in more detail above.

Extractors

To help isolate the DNA that is extracted from the sample, it is bound to ferric oxide particles, allowing for its magnetic capture. This allows the DNA to be isolated from the remainder of the unwanted sample, which can be removed from the eluate using a wash buffer located in the cuvette assembly 4050. To perform this isolation, a magnetic field is applied to the extraction vessels 4026 This is achieved by using an extractor module, which includes enough magnets to ensure that each row of 4026 extraction vessels is close to a magnet on both sides. Said magnets are selectively moved from a position below the extraction containers 4026 to a position adjacent to said containers. This applies the magnetic field that captures the bound DNA to one side of the 4026 extraction vessels.

Extraction protocol

Extraction is achieved by systematically adding various buffers, activating and deactivating the extractor magnets housed in the consumables drawer, and mixing tips. The full extraction operation generally involves the use of 2 4062 pipette tips per sample and uses, in the following order, acid, wash, elution, and neutralization buffers. The 4000 analyzer processes sets of four samples at a time, allowed by the spacing of the 4380 pipettors. To begin, the instrument extracts DNA from a set of four samples using the acid, wash, and elution buffers and performing sample mixing. using a single set of tips, at which time neutralization buffer is added and the 4000 analyzer moves on to the next set of four samples. Once DNA has been eluted from all samples, the 4000 analyzer uses a second set of four 4062 tips for each row of four samples to perform a neutralization mix (discarding the tips after each mix), at which time The extracted DNA is ready for amplification and the instrument proceeds to preamplification step 4608.

Preamplification

The preamplification step 4608 intervenes after the DNA extraction is complete, and is responsible for taking the extracted DNA remaining in the extraction vessels 4026, using it to rehydrate a master mix reagent in an amplification plate 4040, preparing the 4040 amplification for PCR and moving the 4040 plate to the appropriate reader 4260. This process is accomplished by using the 4300 multifunctional robot (both the 4380 pipetters and the 4340 clamp), the 4220 plate sealer, and the 4230 orbital mixer.

Eluate transfer

To move the eluted DNA from the 4026 extraction vessels to the 4040 amplification plate, the 4000 analyzer uses the sequestered/reserved pipette tip for each sample. Each of the 32 DNA samples is transferred to three wells 4042 on amplification plate 4040. This is achieved through a triple distribution, in which enough sample for all three distributions is aspirated from four extraction vessels 4026 to the time using four 4380 sample pipetters. After aspiration, the 4300 robot moves over the amplification plate 4040 and distributes sequentially into each of the three 4042 wells that are filled with each sample. After this distribution, three (default) wells 4042 are filled with neutralized DNA elution each. The spent tips 4062 are then dumped into waste 4210 and the process is repeated for the remaining seven rows of four extraction vessels 4020.

Plate sealing

Once the eluted DNA is transferred to the 4040 amplification plate, the 4040 plate is moved to the 4220 plate sealer where it is sealed. To transport the plate 4040, the robot 4300 is positioned so that the gripper mechanism 4340 hovers over the amplification plate 4040. The gripper arms 4344a-b open, the gripper 4340 lowers, and the arms 4344a-b close. to engage the plate 4040. Sensors in the gripping arms 4344a -b indicate the moment at which the teeth of the gripper have engaged the plate 4040.

Once engaged, the plate 4040 is lifted and transported by the robot 4300 to the plate sealer 4220. The plate 4040 is deposited in the waiting stage 4224 of the sealer 4220, the arms 4344a-b are disengaged and the gripper 4340 is released vertically. . To apply the plate seal, the 4220 sealer places the 4040 amplification plate under a heated plate, delivers a section of the cut sealing material onto the 4040 plate, and lowers the plate to use heat and pressure to bond the sealing material to plate 4040. After sealing, stage 4224 is ejected and plate 4040 is available for transport.

plate mix

Once the plate 4040 has been sealed, rehydration of the master mix drying reagent is performed within the amplification plate 4040. Once again, the plate gripper module 4340 of the robot 4300 engages and lifts the plate 4040. and transports it to a preselected 4230 orbital mixer. Once the 4040 plate has been placed in the 4230 mixer, the clamping arms engage to lock the plate in place. To complete rehydration, the 4040 plate is rotated at a speed that ensures complete mixing of the eluate and drying reagent, while preventing liquid from splashing onto the plate seal.

Transfer to reader

Once the 4040 plate has been completely processed for PCR amplification, it is transported to the 4260 reader for amplification. To prepare the reader 4260 to accept the plate 4040, the reader cavity is opened and any plate 4040 held in the reader is moved to the scrap 4004 using the plate transfer module 4320 on the robot 4300. The robot 4300 then retrieves the plate released 4040 from the mixer 4230 and moves it to the preselected reader 4260. Once the plate 4040 has been placed in the reader 4260, amplification and detection can begin.

Amplification and detection

Once the 4040 plate has been placed in the 4260 reader, the analyzer control software, through the 4412 processor, initiates a PCR protocol that allows the 4260 reader to amplify the installed sample, monitor its amplification in real time, and return curve data that can be translated into a result on each of the molecular assay targets, which in turn allows for HPV detection and genotyping.

Rehearsal time

The PCR protocol takes approximately 2 hours after initiation to complete. To maximize performance, the 4000 analyzer takes advantage of the difference in extraction (~1 h) and amplification/detection (~2 h) processes. Once a sample has been placed in the reader 4260 and the amplification and detection step 4610 has begun, a second set of samples can begin to move through the process. These samples will be advanced to the second reader 4260b; starting the PCR approximately 1 hour after the protocol begins on the first 4260a reader. A third set of samples can then be moved through the extraction process, finishing in time to be placed in the first 4260a PCR reader, which recently completed its first amplification. By alternating samples between the two 4260a-b readers, it is possible to maximize the number of samples moving through the extraction process.

The user loads a quantity of consumables per run or per day to ensure full test performance. In one embodiment, the consumable drawers 4100 in the analyzer 4000 provide a platform on which samples 03 are processed and DNA is extracted. Each of these is used one at a time, meaning that at any given time, several are not in use (and in a charged or consumed state). The analyzer 4000 is configured, through instructions 4416 in its memory 4414, so that these drawers 4100 can be ejected and accessed without requiring the user to access the internal cover of the analyzer 4000 and stop the movement of the robot 4300. At any time, a visual indicator (e.g., colored LED) in each drawer 4110, 4120 indicates its status (ready to use, in use, spent). All drawers 4100 that are not currently in use can be accessed by the user at any time, so that all spent drawers can be replenished at the user's convenience.

When each drawer 4120 is ejected, the user removes and replaces the used amplification cup holders 4020 and empty tip holders 4060. The user also adds an unused amplification plate 4040 to the drawer 4120. Once the drawer 4120 is reinserted, the instrument re-inventories that particular drawer 4120 to check for loading errors and update its internal inventory, marking the drawer as ready for a pull.

Refilling extraction trays

The 4050 extraction cuvette assemblies contain enough liquid reagent for about 18 extractions, which is enough to last a full 24-hour period at maximum throughput. Since it may be unknown how much throughput may be needed for a particular day, two 4050 reagent cuvette assemblies sit on the plate instead of one large cuvette assembly. This allows each bucket to be completely consumed before using the second bucket, minimizing waste. Since such cuvettes can last for a period of 24 hours, such 4050 cuvettes are typically recharged during a daily cleaning protocol. During operation, the 4000 analyzer monitors the volume and indicates to the user which 4050 cuvettes, if any, may need to be replaced.

An example of what is described herein is an automated analyzer having: i) a processing plate comprising a shuttle transfer station, the shuttle transfer station further comprising a conveyor for carrying a shuttle received by the automated analyzer to the shuttle transfer station, the shuttle being a rack comprising a plurality of receptacles, each receptacle adapted to receive a sample container; ii) a support for at least one drilling tool arranged on the processing plate; iii) a robot comprising a gripper; iv) a station configured to receive a consumable reagent cuvette. In this example, the robot, using the gripper, moves a drilling tool from the holder to the station that receives a consumable reagent cuvette and lowers the drilling tool onto the station configured to receive a consumable reagent cuvette. In one example, the robot is a multipurpose robot that has: i) a gantry; and ii) a payload movably connected to the gantry, the payload carrying the clamp and a pipettor module having a plurality of pipette heads, each of them being connectable to a pipette tip. The gripper has a plurality of movable arms capable of cooperative lateral movement to grasp and release items. The robot also has a back panel connector that has a housing and a plurality of general purpose connectors attached to the housing. The pipettor module and clamp are each connected to the rear panel connector housing and the plurality of general purpose connectors thereof in this example.

The above drilling tool holder has a housing defining a cavity sized to receive a drilling tool and a plurality of retaining members movably connected to the housing. The plurality of retention members are movable from a first position in which the retention members engage the drilling tool when present in the drilling tool holder to a second position in which the retention members disengage from the tool. drilling tool, allowing the drilling tool to be placed in and removed from the holder. In one example, the drilling tool holder includes a plurality of posts extending from a base of the housing. Posts can be made tapered at the distal end of the post from the base.

In one example, the gripper has at least two gripping arms. Each of the at least two gripping arms has a gripping finger attached thereto, where the gripping arms move laterally relative to each other such that, in a first position, the gripping arms are separated by a lateral distance that is greater than the lateral separation distance in a second position. In another example, the clamp has at least two holding members. For example, each of the at least two clamping members moves laterally relative to each other such that, in a first position, the clamping members are separated by a lateral distance that is greater than the lateral separation distance in a second position. .

In another example, the at least two gripping fingers and/or the at least two holding members each have a projection. In one example, when the gripper is placed on the support, the gripper fingers engage and are biased against the retaining members when the gripper fingers are in the first position and do not engage the retaining members when they are in the first position. in the second position.

In one example, the drilling tool has a tool body and a plurality of cannulated drilling members extending from the tool body, each of the cannulated drilling members defining an opening extending through the tool body. and each being sized to allow a pipette tip to pass therethrough, each cannulated piercing member also defining an edge configured to penetrate a penetrable cap. The drilling tool comprises openings that are configured to receive the posts when the drilling tool is placed in the holder.

In another example, the shuttle transfer station has a shuttle retention platform that includes a jaw assembly with an open position and a closed position, the jaw assembly being in the open position when the shuttle is received on the shuttle platform. shuttle hold. The jaw assembly also has latching lugs. When the jaw assembly is in the closed position, the latching lugs secure against the bottoms of the containers carried by the shuttle. The jaw assembly is configured so that the latching projections pass through openings in the side of a shuttle received by the shuttle retaining platform when the jaw is in the closed position, forcing the latching projections to come into contact with the bottom parts of the sample containers arranged in the shuttle. The latching lugs do not extend into the shuttle openings when the jaw is in the open position. In another example, the jaw assembly has a drip screen that is secured around sample containers disposed on the shuttle when the jaws are in the closed position. In another example, the shuttle holding platform has an input lane and an output lane and the shuttle holding platform receives the shuttle on the output lane and the shuttle holding platform is equipped with an impeller that moves the shuttle. jaw assembly with shuttle from the output belt to the input belt.

Also described herein is a set of extraction container holders with: i) a lower tray comprising a series of openings; ii) an upper tray having a series of openings. When the bottom tray and top tray are assembled together, the bottom openings align with the top openings. The set includes an arrangement of extraction tubes joined together as a strip. When the extraction tube strip is assembled with the bottom tray, the extraction tubes fit through the openings in the bottom tray and the strip prevents the tubes from passing through the openings so that the strip rests on top of the tray. lower tray. In one example, there is a layer disposed over the strip and an array of draw tubes supported by the strip, and the layer formed over the draw tubes is a seal and wherein the seal is a puncture seal. In another example, the lower tray has upward-facing side walls and, when the upper tray is assembled with the lower tray, the upper tray fits within the confines of the upward-facing side walls of the lower tray. The upper tray of the assembly may have support ribs that are positioned on the upper tray in a direction orthogonal to the strip supported by the lower tray. The seals on the extraction tubes are exposed through the openings in the upper tray when the upper and lower trays are assembled together with the strip between them. In another example, a barcode is placed on the top tray, where the information associated with the barcode includes at least one of a manufacturing lot of the extraction tubes, an expiration date of the extraction tubes or the serial number of the extraction tubes. In another example, the bottom tray has an element on the upwardly extending side walls that engages with a corresponding element in a drawer for housing the extraction container assembly that provides a clamping of the extraction tube container assembly in the drawer.

Also described herein is a drilling tool assembly having: i) a drilling tool having a tool body and a plurality of cannulated drilling members extending from the tool body, each of the drilling elements defining cannulated an opening extending through the tool body and each being sized to allow a pipette tip to pass therethrough, each cannulated piercing member also defining an edge configured to penetrate a penetrable cap and where each of The buckets are covered by the penetrable lid before being penetrated by the respective cannulated drilling members; and ii) a drilling tool holder having a housing defining a cavity sized to receive the drilling tool and a plurality of retaining members movably connected to the housing, the plurality of retaining members being movable from a first position in which the retention members engage the drilling tool to a second position in which the retention members are disengaged from the drilling tool. The drilling tool holder may have a plurality of posts extending from a base of the housing. Posts can be made tapered at the distal end of the post from the base.

Also described here is a multipurpose robot having: i) a gantry; and ii) a payload movably connected to the gantry. The payload has: i) a pipettor module having a plurality of pipette heads, each of which is connectable to a pipette tip; ii) a gripper module having a plurality of movable arms for grasping consumable items; and iii) a back panel connector having a housing and a plurality of general purpose connectors coupled to the housing, the general purpose connectors being configured to supply at least one of power, data or vacuum pressure to the payload and The pipettor module and the clamp module are each connected to the rear panel connector housing and the plurality of general purpose connectors thereof. In one example, the gripper has at least two gripping arms, each of the at least two gripping arms having a gripping finger attached thereto. The gripping arms move laterally relative to each other so that, in a first position, the gripping arms are separated by a lateral distance that is greater than the lateral separation distance in a second position. The clamp may have a plurality of holding members. In this example, the at least two holding members move laterally relative to each other such that, in a first position, the holding members are separated by a lateral distance that is greater than the lateral separation distance in a second position. In another example, the at least two gripping fingers and/or the at least two holding members each have a projection.

A method of obtaining reagents for a test in an automated analyzer is also described, in which the following steps are performed: i) moving a payload from the robot to a drilling tool holder in which a drilling tool is arranged , the payload of the robot carrying a pipetter module and a gripper module, the gripper module having at least two gripping arms, each gripping arm comprising a gripping member and a finger; ii) engaging projections of the holding member of the gripping arm with a corresponding linking member of the drilling tool by moving the gripping arms from a first position to a second position; iii) moving the robot carrying the drilling tool to a liquid container at a second location, the liquid container having one or more penetrable lids covering a plurality of compartments containing liquid reagents; iv) lowering the drilling tool onto the liquid container so that the cannulated drilling members extending from the drilling tool penetrate the one or more lids of the liquid container and each cannulated drilling member enters a different compartment of the liquid container; v) releasing the drilling tool from the robot by moving the gripping arms inward and closer together so that the projections are removed from the linking member of the drilling tool; vi) introducing a pipette tip of the pipettor module through at least one of the cannulated drilling members and into contact with the liquid reagent arranged in the compartment crossed by the drilling member; vii) aspirate a liquid reagent from the compartment; and viii) transfer the liquid reagent to a tube adapted to receive a sample for analysis. In the method, a respective pipette tip may be introduced through each cannulated piercing member and in contact with the liquid reagents in the compartment punctured by the respective piercing member.

In another exemplary method for obtaining a sample for analysis, said method includes the steps of: i) transporting a first shuttle carrying one or more sample containers to a sample analyzer and a shuttle retention mechanism, the retention mechanism having Opposite shuttle arms arranged along the sides of the shuttle carried therein; ii) moving the opposite arms from a first position in which the shuttle was received to a second position in which, in the second position, the engaging members extending from each opposite arm engage with a bottom part of each container sample arranged on the shuttle so that the engaging members extend through openings in the shuttle when it is in the second position; iii) lowering a pipette tip through the sample lid of the container, thereby puncturing a seal in the lid, the pipette tip extending into the sample disposed in the sample container; iv) aspirate a sample from the sample container of the first shuttle with the pipettor; v) remove the pipette tip from the sample containers; the hooking members remaining engaged with the bottom of each sample container when the pipette is removed; vi) move opposite arms from second position back to first position; and vii) transporting the first shuttle away from the shuttle retention mechanism in a second direction opposite to the first direction. In such a method, the following additional steps can be performed: viii) moving the shuttle laterally from a first rail through which the shuttle advances towards the shuttle retention mechanism to a second rail through which the shuttle is transported out of the analyzer.

Claims (17)

1. An automated analyzer comprising: a processing plate (4014) comprising a shuttle transfer station (4250), the shuttle transfer station (4250) further comprising a conveyor (4254) for carrying a shuttle (4030) received by the automated analyzer to the station shuttle transfer (4250), the shuttle (4030) being a rack comprising a plurality of receptacles (4032), each receptacle (4032) configured to receive a sample container (03); a support (4270) disposed on the processing plate (4014); a drilling tool (4240) placed in the holder (4270); a robot (4300) comprising a gripper (4340); a reagent cuvette station configured to receive a consumable reagent cuvette (4050); a consumable reagent cuvette (4050) disposed in the reagent cuvette station; and wherein the gripper (4340) is adapted to transport a drilling tool (4240) from the holder (4270) to the reagent cuvette station and further adapted to lower the drilling tool (4240) onto the reagent cuvette station. reagent. 2. The automated analyzer of claim 1, wherein the robot (4300) is a multipurpose robot comprising: a portico; and payload movably connected to the gantry, the payload comprising the clamp (4300) and a pipettor module (4380) having a plurality of pipette heads, each of which is connectable to a pipette tip (4062), wherein the clamp comprises a plurality of movable arms (4344a-b) capable of a cooperative lateral movement to grab and release items; and a back panel connector (4360) having a housing and a plurality of general purpose connectors coupled to the housing; wherein the pipettor module (4380) and the clamp are each connected to the housing of the rear panel connector (4360) and the plurality of general purpose connectors thereof. 3. The automated analyzer of claim 2, wherein the support (4270) comprises a housing defining a cavity sized to receive a drilling tool (4240) and a plurality of retaining members (4284) movably connected to the housing, the plurality of retaining members (4284) being movable from a first position in which the retaining members (4284) engage with the drilling tool (4240) when present in the support (4270) to a second position in which the retaining members (4284) are disengaged from the drilling tool (4240) allowing the drilling tool (4240) to be placed in and removed from the support (4270). 4. The automated analyzer of claim 3, wherein the gripper comprises at least two gripping arms (4344a-b), wherein each of the at least two gripping arms (4344a-b) has a finger grip attached thereto, in which the gripping arms (4344a-b) move laterally relative to each other so that, in a first position, the gripping arms (4344a-b) are separated by a lateral distance that is greater than the lateral separation distance in a second position. 5. The automated analyzer of claim 3, wherein the clamp further comprises at least two holding members (4346). 6. The automated analyzer of claim 5, wherein the at least two holding members (4346) are each configured to move laterally relative to each other such that, in a first position, the holding members (4346) They are separated by a lateral distance that is greater than the lateral separation distance in a second position. 7. The automated analyzer of claim 4, wherein each of the at least two gripping fingers (4349) further comprises a projection. 8. The automated analyzer of claim 6, wherein each of the at least two holding members (4346) further comprises a projection. 9. The automated analyzer of claim 4, wherein the gripper is configured to be placed on the holder (4270), the gripping fingers (4349) are configured to move from the first position in which the fingers (4349) are hooked and pressed against the retention members (4284) when the gripping fingers (4349) are in the second position. 10. The automated analyzer of claim 3, wherein the drilling tool (4240) comprises a tool body and a plurality of cannulated drilling members (4244) extending from the tool body, each defining cannulated drilling organs (4244) an opening that extends to through the tool body and each being sized to allow a pipette tip (4062) to pass therethrough, each cannulated piercing member (4244) also defining an edge configured to penetrate a penetrable cover. 11. The automated analyzer of claim 10, wherein the drilling tool (4240) comprises openings that are configured to receive the plurality of posts (4287a-b) when the drilling tool (4240) is placed in the holder ( 4270). 12. The automated analyzer of claim 1, wherein the shuttle transfer station (4250) comprises a shuttle retention platform (4250) for receiving a shuttle (4030), further comprising the shuttle retention platform (4250 ): a jaw assembly (4252) with an open position and a closed position, wherein the jaw assembly (4252) is in the open position when the shuttle (4030) is received on the shuttle retaining platform (4250), the jaw assembly (4252) further comprising latching projections (4253), wherein, when the jaw assembly (4252) is in the closed position, the latching projections (4253) are configured to lock against the bottom portions of the containers carried by the shuttle (4030); wherein the jaw assembly (4252) is configured so that the engagement projections (4253) pass through openings in one side of a shuttle (4030) received by the shuttle retaining platform (4250) when the jaw assembly The jaw (4252) is in the closed position, so the jaw assembly (4252) is configured to force the latching projections (4253) to come into contact with the bottom parts of the sample containers (03) arranged in the shuttle (4030); and wherein the engagement projections (4253) do not extend into the openings of the shuttle when the jaw assembly (4252) is in the open position. 13. The automated analyzer of claim 12, wherein the jaw assembly (4252) further comprises a drip screen that is secured around the sample containers (03) disposed on the shuttle (4030) when the jaw assembly ( 4252) is in the closed position. 14. The automated analyzer of claim 12, wherein the shuttle retention platform (4250) comprises an input lane and an output lane, wherein the shuttle retention platform (4250) receives the shuttle (4030). ) in the exit lane and wherein the shuttle retaining platform (4250) further comprises a driver that moves the jaw assembly (4252) with the shuttle (4030) therein from the exit lane to the entry lane . 15. The automated analyzer of claim 1 further comprising a drilling tool assembly comprising: wherein the drilling tool assembly comprises the drilling tool (4240) having a tool body and a plurality of cannulated drilling members (4244) extending from the tool body, each of the drilling members defining cannulated piercing member (4244) an opening extending through the tool body and each being sized to allow a pipette tip (4062) to pass therethrough, each cannulated piercing member (4244) also defining an edge configured to penetrating a penetrable lid and where each of the buckets (4050) is covered by the penetrable lid before being penetrated by respective cannulated drilling members (4244); and the support (4270) comprising a housing that defines a cavity sized to receive the drilling tool (4240) and a plurality of retaining members (4284) movably connected to the housing, the plurality of retaining members being movable ( 4284) from a first position in which the retaining members (4284) engage with the drilling tool (4240) to a second position in which the retaining members (4284) disengage from the drilling tool (4240) . 16. The automated analyzer of one of claims 3 or 15, wherein the support (4270) further comprises a plurality of posts (4287a-b) extending from a base of the housing. 17. The automated analyzer of claim 16, wherein the posts (4287a-b) are tapered at the distal ends of the plurality of posts (4287a-b) from the base (4282).